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Sintilimab and Anlotinib Combined With Chemotherapy in Neoadjuvant Treatment of Resectable Esophageal Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06015035
Recruitment Status : Completed
First Posted : August 29, 2023
Last Update Posted : August 29, 2023
Sponsor:
Information provided by (Responsible Party):
Xiaolong Yan, Dr., Tang-Du Hospital

Study Description
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Brief Summary:
The study focused on patients with T2-4NxM0 resectable esophageal carcinoma. Neoadjuvant treatment involved administering anlotinib (10 mg orally, once a day, 2 weeks on and 1 week off) for anti-angiogenesis and sintilimab (200 mg) and chemotherapyfor three cycles. Surgical treatment was performed 4-6 weeks after the last chemotherapy cycle was completed. The primary endpoints assessed were pathological complete response (pCR) rate and safety.

Condition or disease Intervention/treatment Phase
Sintilimab and Anlotinib in Combination With Chemotherapy Drug: Sintilimab and anlotinib in combination with chemotherapy Phase 2

Detailed Description:

The study was conducted from April 2021 to April 2022 at our hospital and was approved by the Ethics Committee of Tangdu Hospital. The inclusion criteria were as follows: patients aged 18-75 years with a histopathologic diagnosis of esophageal cancer staged according to the AJCC eighth edition as T1-4N1-3M0. If patients were staged as T2N0M0, the esophageal lesions had to be ≥5 cm. Before enrollment, all patients underwent various examinations, including cardiac color ultrasound (left ventricular ejection fraction of at least 50%), pulmonary function (forced expiratory volume-1 [FEV1] ≥1.5 L), enhanced chest computed tomography (CT), abdominal color ultrasound, cervical lymph node color ultrasound and other necessary laboratory tests (such as blood routine, liver and kidney function, electrolytes, and cortisol rhythm) to exclude treatment and surgical contraindications and ensure suitability for ICIs treatment.

The exclusion criteria were as follows: Patients unable to tolerate surgery, those with refractory hypertension and proteinuria, those who had previously received other treatments, and those who were not suitable candidates for ICIs (due to conditions such as hepatitis B with viral quantification >2000 IU, systemic lupus erythematosus, and xerosis).

Treatment regimen:

Patients were administered preoperatively with sintilimab (200 mg, Day 1) and anlotinib (10 mg, orally, once daily, 2 weeks on and 1 week off) in combination with chemotherapy (albumin paclitaxel 130 mg/m2, Days 1 and 8 + nedaplatin 80 mg/m2, Day 1) for three cycles of neoadjuvant therapy. Surgical intervention (either Mckeown or Ivor Lewis approach) was performed 4-6 weeks after completing the last treatment cycle of neoadjuvant therapy. After the 4th week after surgery, patients received maintenance therapy with sintilimab (200 mg, Q3W) for 1 year. If any adverse reactions of grade 3 or higher occurred during the treatment, the dose of chemotherapeutic drugs was reduced by 25% until the patient's condition recovered to grade 1 or returned to normal, and the subsequent treatment cycle was continued. In case of grade 3 or higher hypertension or proteinuria, the dose of anlotinib was reduced to 8 mg. It was discontinued if the condition could not recover to grade 1-2 after symptomatic treatment.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 17 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Single-center, Single-arm, Open-label Study of Sintilimab and Anlotinib Combined With Chemotherapy in Neoadjuvant Treatment of Resectable Esophageal Cancer
Actual Study Start Date : April 1, 2021
Actual Primary Completion Date : April 1, 2022
Actual Study Completion Date : April 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: anlotinib for anti-angiogenesis and sintilimab and chemotherapy
Neoadjuvant treatment involved administering anlotinib (10 mg orally, once a day, 2 weeks on and 1 week off) for anti-angiogenesis and sintilimab (200 mg) and chemotherapyfor three cycles.
 Drug: Sintilimab and anlotinib in combination with chemotherapy
Neoadjuvant treatment involved administering anlotinib (10 mg orally, once a day, 2 weeks on and 1 week off) for anti-angiogenesis and sintilimab (200 mg) and chemotherapyfor three cycles. Surgical treatment was performed 4-6 weeks after the last chemotherapy cycle was completed. The primary endpoints assessed were pathological complete response (pCR) rate and safety.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Endpoints: pCR [ Time Frame: up to 24 months ]
    PCR: This was assessed by examining the postoperative pathological tissue for the absence of tumor cells in the primary tumor and lymph nodes.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • patients aged 18-75 years with a histopathologic diagnosis of esophageal cancer staged according to the AJCC eighth edition as T1-4N1-3M0. If patients were staged as T2N0M0, the esophageal lesions had to be ≥5 cm.
  • Before enrollment, all patients underwent various examinations, including cardiac color ultrasound (left ventricular ejection fraction of at least 50%), pulmonary function (forced expiratory volume-1 [FEV1] ≥1.5 L), enhanced chest computed tomography (CT), abdominal color ultrasound, cervical lymph node color ultrasound ▪ other necessary laboratory tests (such as blood routine, liver and kidney function, electrolytes, and cortisol rhythm) to exclude treatment and surgical ontraindications and ensure suitability for ICIs treatment.

Exclusion Criteria:

  • Patients unable to tolerate surgery
  • those with refractory hypertension and proteinuria
  • those who had previously received other treatments
  • those who were not suitable candidates for ICIs (due to conditions such as hepatitis B with viral quantification >2000 IU, systemic lupus erythematosus, and xerosis).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06015035


Locations
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China, Shanxi
Hongtao Duan
Xi'an, Shanxi, China, 710038
China
Tangdu Hospital, the Air Force Military University
Xi'an, China, 710038
Sponsors and Collaborators
Tang-Du Hospital
More Information
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Responsible Party: Xiaolong Yan, Dr., Deputy director, Tang-Du Hospital
ClinicalTrials.gov Identifier: NCT06015035    
Other Study ID Numbers: k202204-02
First Posted: August 29, 2023    Key Record Dates
Last Update Posted: August 29, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If the clinical study obtains positive results, it will further expand the study

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Xiaolong Yan, Dr., Tang-Du Hospital:
esophageal cancer; neoadjuvant; efficiency
Additional relevant MeSH terms:
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Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
 Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases